BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2223766 · Received August 25, 2011

    Report

    Report Number
    6000001-2011-20724
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - SAO PAULO
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT HAVE A U.S. 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPANION SAMPLE WAS RETURNED TO THE PLANT FOR EVALUATION. THE REPORTED CONDITION OF "LEAKING" WAS CONFIRMED. A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT IN RELATION TO THE REPORTED CONDITION. THE REPORTED ISSUE WAS CAUSED BY A LACK OF SEALANT DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER TO REPORT 05 EVA BAG-500ML THAT WERE LEAKING. THE BAGS THAT PRESENTED LEAKAGE ARE NOT AVAILABLE FOR EVALUATION. NO PATIENT INVOLVEMENT/INJURY REPORTED. THIS IS REPORT 5 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - SAO PAULO PE28N1

    Patients

    Seq Age Sex Outcome Treatment
    1